Anesthesia Regimens for Hip Replacement Surgery

(BCIS Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Severe aortic stenosis, Anticoagulation, Severe cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day (hospitalization with index surgery)

24 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Administration of general anaesthesia, Neuraxial Analgesia for hip replacement surgery?

Research suggests that neuraxial anesthesia (a type of pain relief given near the spinal cord) is associated with lower risks of complications and death after hip fracture surgery compared to general anesthesia. This implies that using neuraxial analgesia in hip replacement surgery might also lead to better outcomes. ^{1 2 3 4 5}

Is anesthesia for hip replacement surgery generally safe?

Research suggests that neuraxial anesthesia (spinal or epidural anesthesia) is associated with lower risks of postoperative complications compared to general anesthesia in hip fracture surgeries. However, both types of anesthesia are commonly used and considered safe, with ongoing studies focusing on improving safety and outcomes. ^{1 5 6 7 8}

How does the anesthesia regimen for hip replacement surgery differ from other treatments?

The anesthesia regimen for hip replacement surgery combines general anesthesia with neuraxial analgesia (pain relief through the spine), which is unique because it can provide both deep sedation and effective pain management during and after surgery, potentially improving recovery in elderly patients. ^{4 9 10 11 12}

What is the purpose of this trial?

The annual incidence of geriatric hip fractures in the United States is 325,000 and is projected to rise given the aging population.1 The mainstay of treatment is cemented hip hemiarthroplasty. Bone cement implantation syndrome (BCIS) is a serious perioperative complication unique to cemented arthroplasty characterized by hypoxia, hypotension, cardiac arrhythmias, and in severe cases, cardiac arrest. BCIS is associated with significantly higher rates of unplanned intubation, vasopressor use, prolonged hospitalization, and 30-day mortality. Given the rising incidence of hip fractures, the identification of readily modifiable risk factors for BCIS such as anesthetic regimen is crucial to reduce morbidity and mortality. However, a prospective study comparing the rate of BCIS development between general and neuraxial anesthesia is currently lacking. Additionally, no studies have examined how the anesthetic regimen affects histamine and complement levels. Therefore, this pilot study aims to investigate the effect of anesthetic regimen on BCIS development as well as on histamine and complement levels in patients undergoing cemented hemiarthroplasty for hip fracture. The investigators hypothesize that neuraxial anesthesia will be associated with lower rates of BCIS as well as lower histamine and complement levels compared to general anesthesia. The primary objective of this pilot study is to compare the effect of general and neuraxial anesthesia on the incidence and severity of BCIS in patients undergoing cemented hemiarthroplasty for hip fracture. Secondary objectives include examining postoperative outcomes associated with BCIS, such as cardiac arrhythmias, unplanned intubation, hypoxia necessitating supplemental oxygen, altered mental status, and in-hospital mortality. Additional objectives include comparing histamine and complement levels between anesthetic regimens as well as between patients with and without BCIS

Research Team

Adam S. Levin, MD

Principal Investigator

Johns Hopkins Hospital, Dept Orthopedic Surgery, Baltimore, MD 21287

Eligibility Criteria

This trial is for older adults with hip fractures needing cemented hemiarthroplasty. It's not specified who can't join, but typically those with allergies to anesthesia or high risk for surgery complications might be excluded.

Exclusion Criteria

I am unable to understand and give consent due to severe cognitive issues.

I cannot have certain anesthesia due to my other health issues.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants undergo cemented hip hemiarthroplasty under either general or neuraxial anesthesia

1 day (hospitalization with index surgery)

1 visit (in-person)

Postoperative Monitoring

Postoperative complications within 30 days of the index surgery will be identified via chart review

30 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Administration of general anaesthesia
• Neuraxial Analgesia

Trial Overview The study compares general anesthesia versus neuraxial analgesia (spinal block) in preventing BCIS during hip surgery. It also looks at how these methods affect histamine and complement levels in the body.

Participant Groups

Group I: Neuraxial Anesthesia Active Control 1 Intervention

Patients undergoing cemented hemiarthroplasty under neuraxial anesthesia

Group II: General Anesthesia Active Control 1 Intervention

Patients undergoing cemented hemiarthroplasty under general anesthesia

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Findings from Research

In a study of 45,874 patients undergoing hip fracture surgery, neuraxial anesthesia was associated with lower rates of postoperative complications (11.0%) compared to general anesthesia (12.9%).

After adjusting for various factors, general anesthesia was found to significantly increase the risk of postoperative morbidity (19% higher) and mortality (9% higher) compared to neuraxial anesthesia, suggesting that neuraxial anesthesia may lead to better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

General versus Neuraxial Anesthesia on Clinical Outcomes in Patients Receiving Hip Fracture Surgery: An Analysis of the ACS NSQIP Database. Wang, MT., Chang, CC., Liu, CC., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Association of anesthesia and analgesia with long-term mortality after hip fracture surgery: an analysis of the Australian and New Zealand hip fracture registry. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Improve hip fracture outcome in the elderly patient (iHOPE): a study protocol for a pragmatic, multicentre randomised controlled trial to test the efficacy of spinal versus general anaesthesia. [2019]

3. Netherlands pubmed.ncbi.nlm.nih.gov

General versus regional anaesthesia for hip fractures. A pilot randomised controlled trial of 322 patients. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

Ultrasound-guided, direct suprainguinal injection for fascia iliaca block for total hip arthroplasty: A retrospective study. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

General versus Neuraxial Anesthesia on Clinical Outcomes in Patients Receiving Hip Fracture Surgery: An Analysis of the ACS NSQIP Database. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Outcome by mode of anaesthesia for hip fracture surgery. An observational audit of 65 535 patients in a national dataset. [2014]

7. Italy pubmed.ncbi.nlm.nih.gov

Comparison of the effects of general and regional anesthesia on mortality and hospital length of stay in geriatric hip fractures. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Effects of neuraxial or general anaesthesia on postoperative adverse events in oldest-old patients (aged 90 years and older) with intertrochanteric fractures: a retrospective study. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Practice Variations in Anesthetic Care and Its Effect on Clinical Outcomes for Primary Total Hip Arthroplasties. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Combined fascia iliaca compartment block and monitored anesthesia care for geriatric patients with hip fracture: Two case reports. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Peripheral Nerve Block as a Supplement to Light or Deep General Anesthesia in Elderly Patients Receiving Total Hip Arthroplasty: A Prospective Randomized Study. [2018]

12. United States pubmed.ncbi.nlm.nih.gov

Comparison of clinical effects of general anesthesia and intraspinal anesthesia on total hip arthroplasty. [2021]